TruLock

FDA UDI

Class II (US FDA UDI)

by Rmo

Identity

Trade Name: TruLock FDA UDI
Generic Name: Orthodontic bracket adhesive FDA UDI
Device Name: TRULOCK Primer Activated Adhesive Kit (40 Capsule) FDA UDI
Model / Reference: K00082 FDA UDI
Description: TRULOCK Primer Activated Adhesive Kit (40 Capsule) FDA UDI

Identifiers

Primary DI / UDI-DI: 00885797644930 FDA UDI
FDA Product Code: DYH FDA UDI
GMDN Term: Orthodontic bracket adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic bracket adhesive

TruLock by Rmo — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic bracket adhesive.

Opal Bond — ULTRADENT PRODUCTS, INC. · Class I
ORTHOSOURCE — Ortho Source
Resilience — ORTHO TECHNOLOGY, INC. · Class II
Illuminate — Ortho Organizers, Inc. · Class II
Novocol GRANITEC PRIMER 9ML — Septodont · Class II
Light Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Light Cure Retainer — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
Rely a Bond — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Rmo

Sources (1)

FDA UDI 6cde7d45-a048-4701-95c7-3e2712dc859d 33 fields · synced May 30, 2026